510(k) K183361 ยท QEY Mechanical Thrombolysis Catheter
EkoSonic Endovascular Device with Control Unit 4.0
| Applicant | Btg International, Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Apr 5, 2019 |
| Received | Dec 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2022 | Boston Scientific Corporation EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System. Open, Classified |
QEY | None listed |
| Nov 3, 2020 | Boston Scientific Corporation EKOS Control System (CU) 4.0. UPN 600-40500
The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device Open, Classified |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.